Variations and post approval submissions - NALHN research projects

From time to time, amendments to research projects are required. The forms for these changes should be submitted electronically to the Research Governance Office (RGO) at

Please include:

  • Site-Specific Assessment (SSA) number in the title of the e-mail
  • Complete and attach the appropriate form/s
  • Attach all supporting documents
  • Attach fee form (if applicable)

Ensure that documents in the amendment are appropriately named with the document title, version number, version date (e.g. Protocol_V3_16Jan2018) and that documents are not locked. Do not send unnamed documents (e.g. files from a scanner titled 20188476565). Versions must correspond with the HREC approval.

Attach each document separately to one email (e.g. a separate file for the cover letter, protocol, PICF). Do not combine into a single PDF.

If the file is too large, please attach over a series of emails making it clear in the subject (e.g. SSA/16/NALHN/## Email 1 of 3).

If the amendment includes documents that require an original signature such as CTRAs, please ALSO submit these in hard copy to the RGO with a copy of the amendment form.

Variations and Post Approval Forms

Post approval Variation Cover Sheet (DOCX 96KB) - We understand that things change. Please complete and submit this checklist with all of your supporting documents so that we can ensure the RGO has received all required documentation.

NALHN RGO Submission Documents Checklist (DOCX 71KB) - Summary of all requirements, bank details, contractor details etc

NALHN RGO Annual Report Cover Sheet (DOCX 64KB) - Most projects need an annual report. Please use this cover-sheet when submitting your annual report documents, to help us make sure that everything in your project is up to date.

RGO Fee Form (DOCX 63KB) - Please submit this with your other paperwork, so we know who to invoice.

GEMS Helpful Steps